Head and Neck Squamous Cell CarcinomaNCT05889091
A Study of the Use of Fat Flap Reconstruction to Reduce Neck Injury After Cancer Treatment
A study testing HRQOL instruments and LENT SOMA instrument in people with Head and Neck Squamous Cell Carcinoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to find out whether the fat ALT flap procedure is a safe and practical option for reducing neck morbidity in HNSCC patients following cancer treatment of the neck. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- HRQOL instruments and LENT SOMA instrument
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2023to 16 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years or older
- Diagnosed with HNSCC (e.g., oropharyngeal, hypo/laryngeal SCC)
- Primary treatment is with radiotherapy with or without chemotherapy
- Salvage neck dissection is subsequently indicated for persistent or recurrent, nonmucosal disease in cervical lymph nodes
- At the time of salvage neck dissection additional flap coverage is indicated to improve carotid coverage or replace missing skin
Who cannot join
- Patients with primary site mucosal recurrence in addition to neck disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jennifer Cracchiolo, MD contact
United States1 site, 1 recruiting
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Evan Matros, MD, 646-608-8044
Jennifer Cracchiolo, MD, 212-639-8420
About this study
Official title: The Safety of a Buried, Free Fat Flap to Reduce Neck Morbidity Following Cancer Treatment: A Pilot Study
The purpose of this study is to find out whether the fat ALT flap procedure is a safe and practical option for reducing neck morbidity in HNSCC patients following cancer treatment of the neck. Neck morbidity after radiation therapy and surgery includes difficulty swallowing, neck or shoulder pain, stiffness, swelling, or changes to the appearance of the treated area. In addition, the researchers will find out whether the study procedure is effective at reducing neck morbidity and improving quality of life after cancer treatment. The researchers will measure quality of life by having participants answer questionnaires.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- HRQOL instruments, LENT SOMA instrument
- Keywords
- Free fat flap, Reconstruction, Quality of life, 23-102
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRQOL instrumentsOther
These instruments include Face Q for Appearance, Eating \& drinking, Swallowing, and Saliva (patient-reported); the Neck Dissection Impairment Index (patient-reported); the Long-term ENT-Subjective/Objective/Management/Analysis (LENT-SOMA) for skin-subcutaneous tissue, muscle-soft tissue, mucosa - oral and pharyngeal, salivary gland, and mandible (patient- and clinician-reported); modified barium swallow study (8-point penetration aspiration scale).
LENT SOMA instrumentOther
LENT SOMA instrument will also be provided to summarize objective quality-of-life-related measures recorded at 12 months postoperatively, including interincisor distance (mm); neck range of motion measured in degrees of flexion, extension, lateral flexion, and rotation to both sides; and shoulder range of motion, measured in degrees of abduction.
| Study group | Role | What they receive |
|---|---|---|
| Quality of life questionnaires | Experimental | After the Fat Flap Reconstruction at 6 months post-operatively, all patients will be asked to complete the selected patient reported outcomes instruments and to complete clinical assessment with either the Head and Neck Surgery (HNS) or Plastic \& Reconstructing Surgery (PLA) care team. Range of Motion (ROM) measurements using a goniometer will be completed by a member of the HNS clinical team. At 12 months post-operatively, all patients will be asked to complete the selected patient reported outcomes instruments and to complete clinical assessment. Patients will be asked to complete inter-incisor distance measurement and barium swallow assessment, done by a member of the SLP team. Range of Motion (ROM) measurements using a goniometer will be completed by a member of the HNS clinical team. Receives: Other: HRQOL instruments; Other: LENT SOMA instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients that experience a complications
Flap-related surgical complications - subjective and objective outcomes using validated instruments and CTCAE V5.0 i. Partial/total flap loss ii. Venous/arterial thrombosis iii. Infection iv. Hematoma v. Seroma Donor site i. Hematoma ii. Infection iii. Seroma iv. Dehiscence
Measured: within 90 days post operatively
Secondary outcomes (1)
changes in HRQOL scores
Appearance scores in HNSCC patients is +/- 18.1 if a similar standard deviation is observed. For the Face-Q Eating \& Drinking, the standard deviation is 22, corresponding to a half width of +/- 12.4. For the Face-Q Swallowing, the standard deviation is 26, corresponding to a half width of +/- 14.7. For the Face-Q Saliva, the standard deviation is 27, corresponding to a half width of +/- 15.3. Due to the small sample size of this study, examination of the HRQOL scores will be exploratory and hypothesis generating in nature.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start16 May 2023
- Primary completion16 May 2027 (estimated)
- Study completion16 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a descriptive, single-arm pilot study.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evan Matros, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889091
- Sponsor's protocol ID
- 23-102
- Status last verified
- Jun 2026
- First submitted
- 17 May 2023
- Last updated
- 3 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety of a Buried, Free Fat Flap to Reduce Neck Morbidity Following Cancer Treatment: A Pilot Study
- ClinicalTrials.gov ID
- NCT05889091
- Acronym / sponsor ID
- 23-102
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- Free fat flap, Reconstruction, Quality of life, 23-102
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 16 May 2023 (actual)
- Primary completion
- 16 May 2027 (estimated)
- Study completion
- 16 May 2027 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out whether the fat ALT flap procedure is a safe and practical option for reducing neck morbidity in HNSCC patients following cancer treatment of the neck. Neck morbidity after radiation therapy and surgery includes difficulty swallowing, neck or shoulder pain, stiffness, swelling, or changes to the appearance of the treated area. In addition, the researchers will find out whether the study procedure is effective at reducing neck morbidity and improving quality of life after cancer treatment. The researchers will measure quality of life by having participants answer questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a descriptive, single-arm pilot study.
| Arm | Type | Receives |
|---|---|---|
| Quality of life questionnaires | Experimental | Other: HRQOL instruments, Other: LENT SOMA instrumentAfter the Fat Flap Reconstruction at 6 months post-operatively, all patients will be asked to complete the selected patient reported outcomes instruments and to complete clinical assessment with either the Head and Neck Surgery (HNS) or Plastic \& Reconstructing Surgery (PLA) care team. Range of Motion (ROM) measurements using a goniometer will be completed by a member of the HNS clinical team. At 12 months post-operatively, all patients will be asked to complete the selected patient reported outcomes instruments and to complete clinical assessment. Patients will be asked to complete inter-incisor distance measurement and barium swallow assessment, done by a member of the SLP team. Range of Motion (ROM) measurements using a goniometer will be completed by a member of the HNS clinical team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients 18 years or older
- Diagnosed with HNSCC (e.g., oropharyngeal, hypo/laryngeal SCC)
- Primary treatment is with radiotherapy with or without chemotherapy
- Salvage neck dissection is subsequently indicated for persistent or recurrent, nonmucosal disease in cervical lymph nodes
- At the time of salvage neck dissection additional flap coverage is indicated to improve carotid coverage or replace missing skin
Key exclusion criteria (1 listed)
- Patients with primary site mucosal recurrence in addition to neck disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRQOL instrumentsThese instruments include Face Q for Appearance, Eating \& drinking, Swallowing, and Saliva (patient-reported); the Neck Dissection Impairment Index (patient-reported); the Long-term ENT-Subjective/Objective/Management/Analysis (LENT-SOMA) for skin-subcutaneous tissue, muscle-soft tissue, mucosa - oral and pharyngeal, salivary gland, and mandible (patient- and clinician-reported); modified barium swallow study (8-point penetration aspiration scale). | Other | Quality of life questionnaires |
| LENT SOMA instrumentLENT SOMA instrument will also be provided to summarize objective quality-of-life-related measures recorded at 12 months postoperatively, including interincisor distance (mm); neck range of motion measured in degrees of flexion, extension, lateral flexion, and rotation to both sides; and shoulder range of motion, measured in degrees of abduction. | Other | Quality of life questionnaires |
Primary outcome
Proportion of patients that experience a complications
Time frame: within 90 days post operatively
Flap-related surgical complications - subjective and objective outcomes using validated instruments and CTCAE V5.0 i. Partial/total flap loss ii. Venous/arterial thrombosis iii. Infection iv. Hematoma v. Seroma Donor site i. Hematoma ii. Infection iii. Seroma iv. Dehiscence
1 secondary outcome
changes in HRQOL scores
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Cracchiolo, MD contact
Evan Matros, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HRQOL instruments and LENT SOMA instrument in people with Head and Neck Squamous Cell Carcinoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evan Matros, MD (646-608-8044, matrose@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients that experience a complications (time frame: within 90 days post operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.